Status:
UNKNOWN
Multi-Center Randomized Clinical Trial Irreversible Electroporation for the Ablation of Localized Prostate Cancer
Lead Sponsor:
Clinical Research Office of the Endourological Society
Conditions:
Prostate Cancer
Eligibility:
MALE
50-100 years
Phase:
PHASE2
Brief Summary
Multi-centre Randomized Clinical Trial: 106 patients with confirmed unilateral high-volume low risk (Gleason score 3 + 3) or intermediate risk prostate cancer (Gleason score 3 + 4) will undergo an IRE...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Histologically confirmed organ-confined unilateral prostate cancer with adjacent positive biopsies on transperineal template prostate biopsies or MRI targeted biopsies in combination with systematic biopsies (clinical stage T1c-T2b)
- Gleason sum score 6 or 7
- PSA \<15 ng/ml or PSA \> 15 ng/mL counselled with caution
- Life expectancy of \> 10 years
- Exclusion Criteria
- Bleeding disorder as determined by prothrombin time (PT) \> 14.5 seconds, partial thromboplastin time (PTT) \> 34 seconds, and Platelet Count \< 140/uL
- No ability to stop anticoagulant or anti-platelet therapy for 7 days prior the procedure.
- Active urinary tract infection (UTI)
- History of bladder neck contracture
- Anaesthesia Surgical Assignment category IV or greater
- History of inflammatory bowel disease
- Concurrent major debilitating illness
- Prior or concurrent malignancy except for basal cell carcinoma of the skin
- Cardiac history including arrhythmias, ICD or pacemaker
- Prostate calcifications greater than 5 mm.
- Biologic or chemotherapy for prostate cancer
- Hormonal therapy for prostate cancer within 6 months prior to procedure
- Previous radiation to pelvis
- Transurethral resection of the prostate / Urethral stent
- Prior major rectal surgery (except haemorrhoids)
Exclusion
Key Trial Info
Start Date :
June 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2025
Estimated Enrollment :
106 Patients enrolled
Trial Details
Trial ID
NCT01835977
Start Date
June 1 2015
End Date
January 1 2025
Last Update
December 16 2020
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